エドガーで原本を確認する
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 14, 2025
BENITEC BIOPHARMA INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39267 | 84-4620206 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| 3940 Trust Way, Hayward, California | 94545 | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s Telephone Number, Including Area Code: (510) 780-0819
(Former Name or Former Address, if Changed Since Last Report): Not Applicable
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading |
Name of each exchange |
||
| Common Stock, par value $0.0001 | BNTC | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter)
Emerging Growth Company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02 | Results of Operations and Financial Condition. |
On May 14, 2025, Benitec Biopharma Inc. (the “Company”) issued a press release announcing the Company’s financial results for its fiscal quarter ended March 31, 2025. A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information included in this Current Report on Form 8-K (including Exhibit 99.1 hereto) that is furnished pursuant to this Item 2.02 shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. In addition, the information included in this Current Report on Form 8-K (including Exhibit 99.1 hereto) that is furnished pursuant to this Item 2.02 shall not be incorporated by reference into any filing of the Registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference into such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit |
Description |
|
| 99.1 | Press Release of Benitec Biopharma Inc. dated May 14, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| BENITEC BIOPHARMA INC. | ||||||
| Date: May 14, 2025 | By: | /s/ Dr. Jerel A. Banks |
||||
| Name: | Dr. Jerel A. Banks | |||||
| Title: | Chief Executive Officer | |||||
Exhibit 99.1
Benitec Biopharma Releases Third Quarter 2025 Financial Results
HAYWARD, Calif., May 14, 2025 (GLOBE NEWSWIRE) — Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference (“ddRNAi”) platform, today announced financial results for its third fiscal quarter ended March 31, 2025. The Company has filed its quarterly report on Form 10-Q with the U.S. Securities and Exchange Commission.
“We are profoundly honored to be closely engaged with the OPMD patient community and are thankful for the support of the Subjects and their families as we remain focused on the continued development of BB-301 for the treatment of dysphagia in OPMD patients,” said Jerel A. Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec. “The sixth and final Subject of Cohort 1 was safely treated with the low dose of BB-301 in April 2025. We look forward to enrolling additional Subjects at the next, higher dose of BB-301 later this year. Additional clinical study updates for Subjects enrolled in Cohort 1 are planned for the fourth calendar quarter of this year.”
Financial Highlights
Third Fiscal Quarter 2025 Financial Results
Total Expenses for the quarter ended March 31, 2025, were $10.2 million compared to $4.1 million for the quarter ended March 31, 2024. The Company incurred $6.0 million of research and development expenses compared to $2.6 million for the comparable quarter ended March 31, 2024. Research and development expenses relate primarily to ongoing clinical development of BB-301 for the treatment of OPMD. General and administrative expenses were $4.2 million compared to $1.6 million for the quarter ended March 31, 2024.
The loss from operations for the quarter ended March 31, 2025, was $10.2 million compared to a loss of $4.1 million for the quarter ended March 31, 2024. Net loss attributable to shareholders for the quarter ended March 31, 2025, was $9.4 million, or $0.24 per basic and diluted share, compared to a net loss of $4.3 million, or $0.23 per basic and diluted share for the quarter ended March 31, 2024. The basic earnings per share calculation has been revised to include pre-funded warrants in the weighted number of shares outstanding for the current period and the comparative periods. As of March 31, 2025, the Company had $103.6 million in cash and cash equivalents.
BENITEC BIOPHARMA INC.
Consolidated Balance Sheets
(in thousands, except par value and share amounts)
| March 31, | June 30, | |||||||
| 2025 | 2024 | |||||||
| (Unaudited) | ||||||||
| Assets |
||||||||
| Current assets: |
||||||||
| Cash and cash equivalents |
$ | 103,583 | $ | 50,866 | ||||
| Restricted Cash |
63 | 63 | ||||||
| Trade and other receivables |
3 | 229 | ||||||
| Prepaid and other assets |
361 | 516 | ||||||
|
|
|
|
|
|||||
| Total current assets |
104,010 | 51,674 | ||||||
|
|
|
|
|
|||||
| Property and equipment, net |
145 | 179 | ||||||
| Deposits |
55 | 25 | ||||||
| Other assets |
35 | 62 | ||||||
| Right-of-use assets |
964 | 270 | ||||||
|
|
|
|
|
|||||
| Total assets |
$ | 105,209 | $ | 52,210 | ||||
|
|
|
|
|
|||||
| Liabilities and Stockholders’ Equity |
||||||||
| Current liabilities: |
||||||||
| Trade and other payables |
$ | 6,254 | $ | 4,165 | ||||
| Accrued employee benefits |
426 | 475 | ||||||
| Lease liabilities, current portion |
346 | 284 | ||||||
|
|
|
|
|
|||||
| Total current liabilities |
7,026 | 4,924 | ||||||
|
|
|
|
|
|||||
| Non-current accrued employee benefits |
— | 38 | ||||||
| Lease liabilities, less current portion |
613 | — | ||||||
|
|
|
|
|
|||||
| Total liabilities |
7,639 | 4,962 | ||||||
|
|
|
|
|
|||||
| Stockholders’ equity: |
||||||||
| Preferred stock, $0.0001 par value - 5,000,000 shares authorized; no shares issued and outstanding at March 31, 2025 and June 30, 2024, respectively |
— | — | ||||||
| Common stock, $0.0001 par value - 160,000,000 shares authorized; 25,546,288 and 10,086,119 shares issued and outstanding at March 31, 2025 and June 30, 2024, respectively |
2 | 1 | ||||||
| Additional paid-in capital |
310,313 | 238,398 | ||||||
| Accumulated deficit |
(212,029 | ) | (190,259 | ) | ||||
| Accumulated other comprehensive loss |
(716 | ) | (892 | ) | ||||
|
|
|
|
|
|||||
| Total stockholders’ equity |
97,570 | 47,248 | ||||||
|
|
|
|
|
|||||
| Total liabilities and stockholders’ equity |
$ | 105,209 | $ | 52,210 | ||||
|
|
|
|
|
|||||
BENITEC BIOPHARMA INC.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
| Three Months Ended March 31, | Nine Months Ended March 31, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenues |
$ | — | $ | — | $ | — | $ | — | ||||||||
| Operating expenses |
||||||||||||||||
| Royalties and license fees |
— | (3 | ) | — | (108 | ) | ||||||||||
| Research and development |
5,980 | 2,566 | 14,637 | 12,097 | ||||||||||||
| General and administrative |
4,208 | 1,578 | 9,952 | 4,953 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total operating expenses |
10,188 | 4,141 | 24,589 | 16,942 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Loss from operations |
(10,188 | ) | (4,141 | ) | (24,589 | ) | (16,942 | ) | ||||||||
| Other income (loss): |
||||||||||||||||
| Foreign currency transaction gain (loss) |
11 | (118 | ) | (190 | ) | (22 | ) | |||||||||
| Interest income (expense), net |
823 | (4 | ) | 2,250 | (16 | ) | ||||||||||
| Other income (expense), net |
— | (16 | ) | (5 | ) | (50 | ) | |||||||||
| Gain on extinguishment of liabilities |
— | — | 764 | — | ||||||||||||
| Unrealized gain (loss) on investment |
— | — | — | (1 | ) | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total other income (loss), net |
834 | (138 | ) | 2,819 | (89 | ) | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss |
$ | (9,354 | ) | $ | (4,279 | ) | $ | (21,770 | ) | $ | (17,031 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
| Other comprehensive income: |
||||||||||||||||
| Unrealized foreign currency translation gain (loss) |
(28 | ) | 117 | 176 | (5 | ) | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total other comprehensive income |
(28 | ) | 117 | 176 | (5 | ) | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total comprehensive loss |
$ | (9,382 | ) | $ | (4,162 | ) | $ | (21,594 | ) | $ | (17,036 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss |
$ | (9,354 | ) | $ | (4,279 | ) | $ | (21,770 | ) | $ | (17,031 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
| Deemed dividends |
— | — | — | (619 | ) | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss attributable to common shareholders |
$ | (9,354 | ) | $ | (4,279 | ) | $ | (21,770 | ) | $ | (17,650 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss per share: |
||||||||||||||||
| Basic and diluted |
$ | (0.24 | ) | $ | (0.23 | ) | $ | (0.63 | ) | $ | (1.11 | ) | ||||
| Weighted average number of shares outstanding: basic and diluted |
38,599,453 | 18,281,896 | 34,559,870 | 15,876,753 | ||||||||||||
About BB-301
BB-301 is a novel, modified AAV9 capsid expressing a unique, single bifunctional construct promoting co-expression of both codon-optimized Poly-A Binding Protein Nuclear-1 (PABPN1) and two small inhibitory RNAs (siRNAs) against mutant PABPN1 (the causative gene for OPMD). The two siRNAs are modeled into microRNA backbones to silence expression of faulty mutant PABPN1, while allowing expression of the codon-optimized PABPN1 to replace the mutant with a functional version of the protein. We believe the silence and replace mechanism of BB-301 is uniquely positioned for the treatment of OPMD by halting mutant expression while providing a functional replacement protein.
About Benitec Biopharma, Inc.
Benitec Biopharma Inc. (“Benitec” or the “Company”) is a clinical-stage biotechnology company focused on the advancement of novel genetic medicines with headquarters in Hayward, California. The proprietary “Silence and Replace” DNA-directed RNA interference platform combines RNA interference, or RNAi, with gene therapy to create medicines that simultaneously facilitate sustained silencing of disease-causing genes and concomitant delivery of wildtype replacement genes following a single administration of the therapeutic construct. The Company is developing Silence and Replace-based therapeutics for chronic and life-threatening human conditions including Oculopharyngeal Muscular Dystrophy (OPMD). A comprehensive overview of the Company can be found on Benitec’s website at www.benitec.com.
Forward Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release include forward-looking statements, including statements regarding Benitec’s plans to develop and commercialize its product candidates, the timing of the completion of pre-clinical and clinical trials, the timing of the availability of data from our clinical trials, the timing and sufficiency of patient enrollment and dosing in clinical trials, the timing of expected regulatory filings, and the clinical utility and potential attributes and benefits of ddRNAi and Benitec’s product candidates, and other forward-looking statements.
These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: the success of our plans to develop and potentially commercialize our product candidates; the timing of the completion of preclinical studies and clinical trials; the timing and sufficiency of patient enrollment and dosing in any future clinical trials; the timing of the availability of data from our clinical trials; the timing and outcome of regulatory filings and approvals; the development of novel AAV vectors; our potential future out-licenses and collaborations; the plans of licensees of our technology; the clinical utility and potential attributes and benefits of ddRNAi and our product candidates, including the potential duration of treatment effects and the potential for a “one shot” cure; our intellectual property position and the duration of our patent portfolio; expenses, ongoing losses, future revenue, capital needs and needs for additional financing, and our ability to access additional financing given market conditions and other factors, including our capital structure; the length of time over which we expect our cash and cash equivalents to be sufficient to execute on our business plan; unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA and other governmental authorities and other regulatory developments; the Company’s ability to protect and enforce its patents and other intellectual property rights; the Company’s dependence on its relationships with its collaboration partners and other third parties; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of the Company’s products and the products of the Company’s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; the impact of, and our ability to remediate, the identified material weakness in our internal controls over financial reporting; the impact of local, regional, and national and international economic conditions and events; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission.
The Company disclaims any intent or obligation to update these forward-looking statements.
Investor Relations Contact:
Irina Koffler
LifeSci Advisors, LLC
(917) 734-7387
ikoffler@lifesciadvisors.com